反相高效液相色谱法测定注射用盐酸溴己新的含量及有关物质

Study on RP-HPLC Determination for Content and Related Compounds of Bromhexine Hydrochloride for Injection

目的 反相高效液相色谱法测定注射用盐酸溴己新含量及有关物质.方法 采用SHIMADZU VP-ODS 色谱柱(150 mm×4.6 mm),以甲醇∶乙腈(40∶60)为流动相,流速为0.8 mL·min-1,检测波长为249 nm,柱温为30℃.结果 盐酸溴己新在20 μg·mL-1～70 μg·mL-1浓度范围内,峰面积与浓度呈良好的线性关系,r=0.999 8,平均回收率为99.0%～99.8%,RSD为0.55%～0.64%.结论 该方法操作简便、快速、准确,适用于注射用盐酸溴己新的含量及有关物质的测定.

OBJECTIVE A RP-HPLC method was developed to determine the content and related compounds of Bromhexine Hydrochloride for Injection.METHODS A SHIMADZU C18 column(150 mm×4.6 mm) was used.The mobile phase used were methanol-aceronitrile(40:60) at a flow rate of 0.8mL·min-1,and detected at 249 nm.The column teperature was cotrolled at 40℃. RESULTS The calibration curve was liner in the concentration range of 20 μg·mL-1～70 μg·mL-1(r=0.999 8).Average was 99.0%～99.8%(n=9).CONCLUSION The method is simple,rapid and accurate,it can be used for determining the content and the related and compounds of Bromhexine Hydrochloride for Injection.